Genta Incorporated and Aventis announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Genasense (oblimersen sodium), the first systemic antisense therapy for cancer. The NDA proposes the use of Genasense in combination with dacarbazine for the treatment of patients with advanced melanoma who have not previously received chemotherapy. The FDA also granted Priority Review status to the application, which targets an agency action on or before June 8, 2004.

"This New Drug Application represents the first clinical indication for a drug that promotes chemotherapy-induced apoptosis, the first systemic use of an antisense therapy, and potentially the first new drug for patients with advanced melanoma in almost 30 years," said Loretta Itri, Genta's chief medical officer. "During the review period, we will work closely with the FDA as we seek regulatory approval for this potential new treatment option for patients with advanced melanoma."

"The FDA's decision to grant Genasense a priority review underscores the urgent and significant unmet need for an effective therapy for patients with advanced melanoma. Aventis and Genta are committed to developing and bringing Genasense to market to meet this need, " said Frank Douglas, a member of the Board of Management at Aventis.

Advanced - or malignant - melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4 per cent annually in the US. In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of cancer death in women aged 25 to 29.